Inhibitory Effect of Propofol on Perineal Pruritus in Patients Undergoing Day Surgery

• Sponsor: Yangzhou University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05162430
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 6
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 14.4

Study Details

Study Description

Brief Summary

OBJECTIVE: To investigate the inhibitory effect of different doses of propofol on perineal pruritus induced by dexamethasone sodium phosphate injection in women, with a view to providing clinical reference for comfortable clinical care in day surgery.

METHODS: One hundred and fifty patients with ASA classification I or II undergoing elective day surgery were randomly divided into six groups of P1, P2, P3, P4, P5 and D1, with 25 cases in each group. Before administration of dexamethasone, propofol injection 0.1 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg and 0.5 mg/kg were given intravenously in groups P1, P2, P3, P4 and P5, respectively (injection rate was 5 s), followed by 30 s of intravenous dexamethasone sodium phosphate 10 mg in all five groups; 5 ml of saline was given in group D1, and 30 s After that, dexamethasone sodium phosphate injection was given (injection speed was 5s in all five groups). The perineal itching, the onset and duration of itching, the visual analogue score (VAS) of itching, the sleep disorder sedation score (Ramsay score) and the occurrence of adverse reactions were recorded in the five groups.

Condition or Disease	Intervention/Treatment	Phase
Pruritus Vulvae	Drug: Propofol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Inhibitory Effect of Different Doses of Propofol on Perineal Pruritus Caused by Dexamethasone Sodium Phosphate in Patients Undergoing Day Surgery
• Actual Study Start Date: Jan 20, 2021
• Actual Primary Completion Date: Dec 3, 2021
• Actual Study Completion Date: Dec 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: P1 group Administration of 0.1 mg/kg of propofol and 5mg dexamethasone phosphate sodium	Drug: Propofol; 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s
Experimental: P2 group Administration of 0.2mg/kg of propofol and 5mg dexamethasone phosphate sodium	Drug: Propofol; 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s
Experimental: P3 group Administration of 0.3mg/kg of propofol and 5mg dexamethasone phosphate sodium	Drug: Propofol; 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s
Experimental: P4 group Administration of 0.4 mg/kg of propofol and 5mg dexamethasone phosphate sodium	Drug: Propofol; 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s
Experimental: P5 group Administration of 0.5mg/kg of propofol and 5mg dexamethasone phosphate sodium	Drug: Propofol; 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s
No Intervention: D1 group Administration of 5mg dexamethasone phosphate sodium

Outcome Measures

Primary Outcome Measures

1. Duration of pruritus [3-6 minutes]

   After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end

2. Incidence of pruritus [3-6 minutes]

   Calculation of the occurrence of pruritus in each group.

3. Severity of pruritus [3-6 minutes]

   Pruritus is classified as mild to moderate to severe according to the VAS score.

4. VAS score [10-30 seconds]

   Patients rate their pruritus according to the VAS scale.

5. Ramsay score [10-30 seconds]

   Scoring of patients according to their mental status after administration of propofol.

Secondary Outcome Measures

1. Adverse reactions [3-6 minutes]

   Hypotension, respiratory depression, injection pain after propofol use, record it.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Age 18-65 years old ASA classification I-II grade Body mass index (BMI) 18-30kg/m2

Exclusion Criteria:

Patients with paresthesia or pruritus Drug and alcohol abuse Allergies to lipid drugs and contraindications; corticosteroids are cautious Patients Hyperlipidemia Patients during pregnancy and lactation Mental diseases, communication disorders Patients who use hormones for a long time

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liu meiyu	Yangzhou	Jiangsu	China	225000

Sponsors and Collaborators

• Yangzhou University

Investigators

• Principal Investigator: Liu m yu, Director, Yangzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wang wanxia, student, Yangzhou University
• ClinicalTrials.gov Identifier: NCT05162430
• Other Study ID Numbers: wWang
• First Posted: Dec 17, 2021
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pruritus Vulvae; Pruritus; Propofol

Study Results

No Results Posted as of Dec 17, 2021